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ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Liver Metastases Clinical Trial

Official title:
Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Clinical Trial Summary

To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.

Clinical Trial Description

Primary Objective: • To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy Secondary Objectives: - To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients - To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients - To evaluate the proportion of ctDNA-negative at 1-year post-resection - To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls - To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement - To delineate the pattern of disease recurrence - To assess ctDNA sensitivity and specificity for predicting disease recurrence - To evaluate MDASI-GI during the course of postoperative therapy - To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection - To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy Outcome Measures: Primary: • Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients Secondary: - Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients - Overall survival (OS) among ctDNA-negative and ctDNA-positive patients - ctDNA-negativity at 1-year post-resection - Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics - Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable) - ctDNA sensitivity/specificity for recurrent disease overall by timepoint - MDASI-GI at clinic visits during course of postoperative therapy - Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection - Adverse events ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05062317
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Timothy Newhook
Phone (713) 794-1001
Email tnewhook@mdanderson.org
Status Recruiting
Phase Phase 2
Start date April 26, 2022
Completion date February 28, 2026
View Details
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